An observational study in Hematologic Disorders and Bone Marrow Failure, Hematopoietic Stem Cell Transplantation (HSCT) or Cellular Therapy (CART), sponsored by Henry Ford Health System. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-04-23.
Sponsored by Henry Ford Health System · Observational
Among 298 studies in Hematologic Diseases with a site in United States — 44 open to participants now, 69 under way, 22 of them phase 3. Hematologic Diseases · United States.
Among the 298 studies in Hematologic Diseases with a site in United States, this one is the 31st largest by enrollment of the 39 observational ones that give a count, is one of 17 that started in 2021, is one of 40 observational ones, and was the 237th registered.
609 studies on the registry are indexed under Hematologic Diseases; 108 are open to participants now.
Browse Hematologic Diseases studies →44 of the 298 studies in Hematologic Diseases with a site in United States are open now. Recruiting first, the newest first:
University of Wisconsin, Madison · Sites in United States
Dren Bio · Sites in United States
Atavistik Bio, Inc · Sites in United States, Argentina
Quetzal Therapeutics · Sites in United States, France, Italy and 2 more countries
Washington University School of Medicine · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 72 Hematologic Diseases studies recruiting now, 46 (64%) set no upper age limit and 22 (31%) stop at 75 or younger; 27 take children under 18; 4 take healthy volunteers.
This study: 18 Years to 80 Years · all sexes · no healthy volunteers.
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298 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 69 · Phase 2 108 · Phase 3 58 · Phase 4 7
First in 1988; this study’s year is marked. 17 started in 2021.
This study's enrollment of 33 is below the median of 250 across 127 observational studies indexed under Hematologic Diseases.
Median enrollment 44 across the 247 interventional studies, 482 across the 39 observational. Of the 204 that completed or were terminated, 95 (47%) have results posted.
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147 of 298 have an industry lead sponsor. The 10 most frequent:
Henry Ford Health System is the lead sponsor of 303 studies on the registry; 50 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 26 (70%) have results posted.
Henry Ford Health System has 1 study filed under Hematologic Diseases — fewer than ten, so there is no comparison to draw.
21 of the studies in Hematologic Diseases with a site in United States that are under way reach primary completion within a year, 9 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07059000Phase 3Kedrion S.p.A.A Study Investigating Intravenous Human Normal Immunoglobulin 10% in Adults With Chronic Immune Thrombocytopenia (ITP) | 2026-12 |
| NCT07504458Phase 3Quetzal TherapeuticsPivotal Open-label Phase 3 Clinical Study of QTX-2101 in Adult Patients With Acute Promyelocytic Leukemia | 2027-03 |
| NCT05329649Phase 3Vertex Pharmaceuticals IncorporatedEvaluation of Safety and Efficacy of CTX001 in Pediatric Participants With Severe Sickle Cell Disease (SCD) | 2027-06-06 |
| NCT05477563Phase 3Vertex Pharmaceuticals IncorporatedEvaluation of Efficacy and Safety of a Single Dose of CTX001 in Participants With Transfusion-Dependent β-Thalassemia and Severe Sickle Cell Disease | 2027-06-09 |
| NCT05317416Phase 3PfizerStudy With Elranatamab Versus Lenalidomide in Patients With Newly Diagnosed Multiple Myeloma After Transplant | 2027-08-04 |
Among the 298 studies in Hematologic Diseases with a site in United States, from their registry updates:
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For many patients with hematologic disorders and bone marrow failure, hematopoietic stem cell transplantation (HSCT) or cellular therapy (CART) offers a curative treatment option. Patients after SCT or CART have a variable period of immune deficiency in the post-treatment period. The response to vaccination may affect the outcome of the transplant patients. the immunogenicity of vaccines in this immunosuppressed population is uncertain and variable. HSCT and CAR-T recipients are in a COVID-19 high-risk group and conferring immunity by vaccination at the earliest effective timepoint is desirable. At present, the immunogenicity and efficacy of SARS-CoV-2 vaccines in immune-impaired patients including autologous and allogeneic HSCT recipients is unknown. Furthermore, the impact of GvHD and IST on SARS-CoV-2 vaccine immunogenicity is unknown. the investigators aim to evaluate the vaccination response to COVID vaccines after SCT and CART
so for participants with SCT or CART who decide to get their vaccines, the investigators will measure response by therapy by measuring COVID-19 serology IgG at the following schedule: Baseline +5 days after vaccination; 1 month +/- 10 days (after the first dose), 2 months +/- 10 days (after the 2nd dose), 3 months +/- 10 days, 6 months +/- 10 days and 12 months +/- 10 days In addition, also the investigators will collect CD4 and Total IgG which is the standard of care of these patients post SCT and CART
any SCT or CART post COVID vaccine
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
patients with SCT or CART who decide to get their vaccines we will measure response by therapy by measuring COVID-19 serology IgG at the following schedule: Baseline +5 days after vaccination; 1 month +/- 10 days (after the first dose), 2 months +/- 10 days (after the 2nd dose), 3 months +/- 10 days, 6 months +/- 10 days and 12 months +/- 10 days
estimate range for COVID-19 serology IgG in SCT and CART patients post vaccine
Time frame: up to one year post vaccine
Plan to share: No
No publications or documents are linked to this record.
Ran from Mar 2021 to primary completion in Dec 2023, 32 months.
Of 47 non-industry observational studies under Hematologic Diseases, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 190. This study's 32 months is below that.
Counting every sponsor, half of 64 studies reached it within 51 months; a quarter within 16 and three quarters within 78.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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